Antibody-targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin).


Journal Article

We analyzed the safety and efficacy of Mylotarg (gemtuzumab ozogamicin, an antibody-targeted chemotherapy consisting of a humanized anti-CD33 antibody linked to calicheamicin, a potent antitumor antibiotic) in the treatment of 101 patients > or =60 years of age with acute myeloid leukemia (AML) in untreated first relapse in three open-label trials. Mylotarg is administered as a 2-h intravenous infusion at 9 mg/m(2) for two doses with 14 days between doses. The overall remission rate was 28%, with complete remission (CR) in 13% of patients and complete remission with incomplete platelet recovery (CRp) in 15%. Median survival was 5.4 months for all patients and 14.5 months and 11.8 months for patients achieving CR and CRp, respectively. CD33 antigen is present on normal hematopoietic progenitor cells; thus, an expected high incidence of grade 3 or 4 neutropenia (99%) and thrombocytopenia (99%) was observed. The incidences of grade 3 or 4 elevations of bilirubin and hepatic transaminases were 24% and 15%, respectively. There was a low incidence of grade 3 or 4 mucositis (4%) and infections (27%) and no treatment-related cardiotoxicity, cerebellar toxicity, or alopecia. Mylotarg is an effective treatment for older patients with CD33-positive AML in first relapse and has acceptable toxicity.

Full Text

Duke Authors

Cited Authors

  • Larson, RA; Boogaerts, M; Estey, E; Karanes, C; Stadtmauer, EA; Sievers, EL; Mineur, P; Bennett, JM; Berger, MS; Eten, CB; Munteanu, M; Loken, MR; Van Dongen, JJM; Bernstein, ID; Appelbaum, FR; Mylotarg Study Group,

Published Date

  • September 2002

Published In

Volume / Issue

  • 16 / 9

Start / End Page

  • 1627 - 1636

PubMed ID

  • 12200674

Pubmed Central ID

  • 12200674

International Standard Serial Number (ISSN)

  • 0887-6924

Digital Object Identifier (DOI)

  • 10.1038/sj.leu.2402677


  • eng

Conference Location

  • England